A Clinical Trial to Evaluate the HeartWare™ Ventricular Assist System (ENDURANCE SUPPLEMENTAL TRIAL) (DT2)
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ClinicalTrials.gov Identifier: NCT01966458 |
Recruitment Status
:
Active, not recruiting
First Posted
: October 21, 2013
Results First Posted
: April 23, 2018
Last Update Posted
: April 23, 2018
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Sponsor:
HeartWare, Inc.
Information provided by (Responsible Party):
HeartWare, Inc.
- Study Details
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Tracking Information | |||||||
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First Submitted Date ICMJE | October 17, 2013 | ||||||
First Posted Date ICMJE | October 21, 2013 | ||||||
Results First Submitted Date | February 12, 2018 | ||||||
Results First Posted Date | April 23, 2018 | ||||||
Last Update Posted Date | April 23, 2018 | ||||||
Actual Study Start Date ICMJE | October 2013 | ||||||
Actual Primary Completion Date | August 2016 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures ICMJE |
Number of Participants With Neurologic Injury [ Time Frame: Implant to 12 Months ] The primary endpoint is the percent of participants at 12 months on the originally implanted device with neurologic injury, defined as a stroke with Modified Rankin Scale (MRS) > 0 at 24-weeks post-stroke, or a transient ischemic attack (TIA), or a spinal cord infarction (SCI). The Modified Rankin Scale is scored from 0 to 6, where 0 indicates an absence of symptoms and 6 indicates death. A score of 4 or higher indicates moderately severe or greater disability.
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Original Primary Outcome Measures ICMJE |
Change in stroke incidence at 12 months on the originally implanted HVAD in a new cohort of subjects receiving optimal blood pressure management. [ Time Frame: 12 month ] | ||||||
Change History | Complete list of historical versions of study NCT01966458 on ClinicalTrials.gov Archive Site | ||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
Stroke-free success [ Time Frame: 12 month ] | ||||||
Current Other Outcome Measures ICMJE | Not Provided | ||||||
Original Other Outcome Measures ICMJE | Not Provided | ||||||
Descriptive Information | |||||||
Brief Title ICMJE | A Clinical Trial to Evaluate the HeartWare™ Ventricular Assist System (ENDURANCE SUPPLEMENTAL TRIAL) | ||||||
Official Title ICMJE | A Prospective, Randomized, Controlled, Unblinded, Multi-Center Clinical Trial to Evaluate the HeartWare™ Ventricular Assist Device System for Destination Therapy of Advanced Heart Failure | ||||||
Brief Summary | This is a prospective, randomized, controlled, unblinded, multi-center evaluation of safety and efficacy in patients implanted with a HeartWare® HVAD who receive improved blood pressure management. Subjects have chronic Stage D or NYHA Class IIIB/IV left ventricular failure who have received and failed optimal medical therapy, and who are ineligible for cardiac transplantation. | ||||||
Detailed Description | The study will evaluate non-inferiority of neurologic injury incidence in a new cohort of subjects receiving improved blood pressure management to a control group (i.e., any FDA-approved LVAD for destination therapy). Secondary endpoints include: a comparison of stroke/TIA incidence to a reference observed in the original IDE clinical trial (HW004) that did not specify improved blood pressure management; and non-inferiority of stroke-free success on the originally implanted device to the control group. Subjects will be randomized to HeartWare® HVAD or control LVAD in a 2:1 ratio. Each subject receiving the HeartWare® HVAD or control LVAD is followed to the primary and secondary endpoints at 12 months, with a subsequent follow-up period extending to 60 months post-implant. | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase | Not Applicable | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Chronic Heart Failure | ||||||
Intervention ICMJE |
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Study Arms |
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Active, not recruiting | ||||||
Actual Enrollment ICMJE |
494 | ||||||
Original Estimated Enrollment ICMJE |
429 | ||||||
Estimated Study Completion Date | August 2020 | ||||||
Actual Primary Completion Date | August 2016 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT01966458 | ||||||
Other Study ID Numbers ICMJE | HW004-A | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product | Not Provided | ||||||
IPD Sharing Statement | Not Provided | ||||||
Responsible Party | HeartWare, Inc. | ||||||
Study Sponsor ICMJE | HeartWare, Inc. | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | HeartWare, Inc. | ||||||
Verification Date | March 2018 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |